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Post-Authorisation Safety Studies (PASS)

Meaning

Post-Authorisation Safety Studies (PASS) are formal, structured investigations conducted after a pharmaceutical product, such as a new hormonal therapy, has received regulatory approval and is available for public use. The primary purpose of these studies is to monitor the medicine’s safety profile in a real-world clinical setting, especially to detect rare or long-term adverse effects that may not have been evident during the limited scope of pre-market clinical trials. Regulatory bodies often mandate these studies to assess risks in specific patient populations or to further characterize the incidence of known safety concerns.